Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine
NCT00902824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2013-02-11
Summary
This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.
Conditions
- HIV Infections
Interventions
- BIOLOGICAL
-
ADVAX
Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10\^7 pfu TBC-M4 (IM)
- BIOLOGICAL
-
TBC-M4
Receive 5x10\^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.
- OTHER
-
Placebo
Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector. Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.
Sponsors & Collaborators
-
International AIDS Vaccine Initiative
lead NETWORK
Principal Investigators
-
Brian Gazzard, MD · St. Stephen's Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
Countries
- United Kingdom
Study Locations
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